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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1787-2013 - GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear ...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1788-2013 - GE Healthcare Varicam/VG and VG Hawkeye devices
Product Usage:
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer ...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1789-2013 - Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera
Product Usage:
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for de...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1793-2013 - Optima NM/CT 640
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It in...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1791-2013 - Discovery NM 630, dual detector free-geometry integrated nuclear imaging system.
Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthc...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1792-2013 - Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system.
Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained h...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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Z-1790-2013 - Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system.
Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and d...
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1
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07/24/2013
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FEI # 2126677 GE Healthcare, LLC
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